1、Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsCAN/CSA-Z14161-11(ISO 14161:2009, MOD)National Standard of CanadaNOT FOR RESALE.PUBLICATION NON DESTINE LA REVENTE.Legal Notice for StandardsCanadian Standards Association (CSA) s
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18、r acceptance of the terms and conditions of this Legal Notice.CSA Standards Update ServiceCAN/CSA-Z14161-11March 2011Title:Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsPagination:97 pages (CSA/1CSA/28, ivi, and 63 text)To re
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36、CanadaCAN/CSA-Z14161-11Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsCAN/CSA-Z14161-11Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsCSA/4 Canadian Sta
37、ndards Association March 2011CAN/CSA-Z14161-11Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsCSA PrefaceThis is the second edition of CAN/CSA-Z14161, Sterilization of health care products Biological indicators Guidance for the
38、 selection, use and interpretation of results , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 14161 (second edition, 2009-09-15). It supersedes the previous edition, published in 2006 as CAN/CSA-Z14161 (adopted
39、 ISO 14161:2000).This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Sterilization, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard has been approved as a
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43、. To submit a proposal for change to CSA Standards, please send the following information to inquiriescsa.ca and include “Proposal for change” in the subject line:(a) Standard designation (number);(b) relevant clause, table, and/or figure number;(c) wording of the proposed change; and(d) rationale f
44、or the change.CAN/CSA-Z14161-11Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsMarch 2011 Canadian Standards Association CSA/5Canadian deviationsAdd the following annexAnnex DA (informative)A health care professionals guide to
45、CAN/CSA-Z14161-11, Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of resultsDA.1 ScopeThe ISO 11138 series of Standards specifies general production, labelling, and performance requirements for the manufacture of biological indicators.
46、These Standards provide detailed information on the qualification of biological indicators, but only limited information for the health care professional on the use of biological indicators. In contrast, CAN/CSA-Z14161 contains much useful information on the use of biological indicators, although th
47、is information is presented in a manner that might not be easily understood by the health care professional. Accordingly, this Annex attempts to present the information contained in CAN/CSA-Z14161 in a manner that can be easily interpreted and to address common questions about the use of biological
48、indicators.CAN/CSA-Z14161 consists of 16 main clauses and seven annexes. These provide general information on biological indicators and their use in process development, validation, and routine monitoring. As noted in Clause 1 of CAN/CSA-Z14161, this information is also relevant to health care facil
49、ities employing new sterilization process technologies and biological indicators for which performance Standards have not yet been established. For ease of reference, the clause numbers and clause titles of this Annex parallel the arrangement in CAN/CSA-Z14161. The format employed by many of the clauses of this Annex is to present quotations from CAN/CSA-Z14161 in italic type followed by one or more paragraphs of commentary in roman (non-italic) type. Clauses DA.2, DA.3, DA.7, DA.8, DA.11, and DA.13 provide general information or commen
